An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics

NCT ID: NCT03328975

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-11-01

Brief Summary

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The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.

Detailed Description

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Conditions

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Shoulder Injury Insulin-dependent Diabetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexamethasone

Group 1 will receive an injection of 4mg of dexamethasone 4 mL of 1% lidocaine.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.

Placebo

Group 2 will receive an injection of 5 mL of 1% lidocaine (placebo).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

the placebo group will not receive the corticosteroid medication in their injection to treat the inflammation and pain in their shoulder. Instead, they will receive an injection of 5 mL lidocaine only.

Interventions

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Dexamethasone

The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.

Intervention Type DRUG

Placebo

the placebo group will not receive the corticosteroid medication in their injection to treat the inflammation and pain in their shoulder. Instead, they will receive an injection of 5 mL lidocaine only.

Intervention Type OTHER

Other Intervention Names

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Corticosteroid

Eligibility Criteria

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Inclusion Criteria

* Insulin-dependent diabetic
* Age 18+
* Shoulder pain for over 4 weeks duration that is uncontrolled with activity modification or nonsteroidal anti-inflammatory drugs
* Use of glucometer for blood sugar monitoring
* Well controlled blood glucose levels
* Hemoglobin A1c less than or equal to 7.5

Exclusion Criteria

* Previous corticosteroid injection within the past 6 months
* Active infection
* Pregnant or plan on becoming pregnant
* Previous adverse event with corticosteroid or lidocaine use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Bryson Lesniak

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PRO17070506

Identifier Type: -

Identifier Source: org_study_id